NCI Community Oncology Research Program - Protocol Summary
NSABP B-51 - "A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Breast Clinical Trial
CANCER TYPE: Stage I
RESEARCH BASE: CTSU NSABP B-51
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
Adj., T1-3 N1, (+) axillary nodes b/f & (-) axillary nodes post-neoadjuv chemo; Eval of post-mastectomy chestwall + reg nodal XRT & post-lumpectomy reg nodal XRT (see RT credentialing requirements in protocol.) DCP-001 Eligible
1) See RT credentialing requirements in §4.0.
2) The 1st case from each RT site in each of Groups 1A, 2A, & 2B will undergo rapid review prior to start of tx.
Treatment Plan (Supplied Drug: None)
Arm 1 (Groups 1A & 1B) - No Regional Nodal RT
Group 1A Lumpectomy: Whole breast RT + Boost
Group 1B Mastectomy: No RT
Arm 2 (Groups 2A & 2B) - Regional Nodal RT
Group 2A Lumpectomy: Whole breast RT + Boost + Regional Nodal RT
Group 2B Mastectomy: Chestwall RT & Regional Nodal RT
* All pts will receive additional systemic therapy as planned (i.e., hormonal therapy if hormone receptor-positive breast cancer & Trastuzumab/other anti-HER2 therapy if HER2-positive).
- Female, age >18.
- ECOG perf status 0-1.
- Clinically T1-3 N1 breast cancer at time of dx (b/f neoadjuv therapy). Asmt by palpation, US, CT, MRI, PET, or PET/CT.
- Path-confirmed axillary node involvement b/f neoadjuv therapy based on positive FNA (showing malignant cells) or positive core needle bx (showing invasive adenocarcinoma). FNA or core needle bx may be performed by palpation or image guidance. No documentation of axillary nodal positivity by sentinel node bx (b/f neoadjuv therapy).
- ER analysis performed on prim breast tumor b/x neoadjuv chemo by current ASCO/CAP Guideline Recommendations. If ER-, asmt of PgR must also be performed.
- HER2 testing performed on prim breast tumor b/f neoadjuv chemo by current ASCO/CAP Guideline Recommendations for HER2 Testing in Breast Cancer. HER2+ or HER2- prim tumors are eligible.
- Completed a minimum of 8 wks of standard neoadjuv chemo (anthracycline &/or taxane-based regimen).
- May have <12 wks of adjuvant chemo after surgery, but must be completed b/f randomiz. Dose/Schedule of adjuv chemo at investigator's discretion. NOTE: Preferred that all chemo be administered in neoadjuv setting.
- HER2+ tumors must be treated w/neoadjuv anti-HER2 therapy (with all or with a portion of neoadjuv chemo), unless medically contraindicated.
- At time of definitive surgery, all removed axillary nodes must be histologically cancer-free. Acceptable asmt procedures are: 1) axillary node dissection, 2) sentinel node bx alone if >2 SNs removed (>3 rermoved & use of dual tracer for lymphatic mapping strongly recommended), or 3) sentinel node bx followed by axillary node dissection. Pts eligible whether there is residual invasive carcinoma in surgical specimen or if there is pathologic CR. NOTE: If path node+ at time of surgery based on sentinel node bx alone, pt may be eligible for CTSU Alliance A011202.
- Path stages ypN0(i+) or ypN0(mol+) are eligible.
- Total mastectomy or lumpectomy pts are eligible. Nipple-sparing mastectomy is allowed.
- Lumpectomy pts: Margins of resected specimen or re-excision must be histol-free of invasive tumor & DCIS by local pathologist. Additional operative procedures are allowed to get clear margins. If tumor persists after re-excision(s), pt must have total mastectomy to be eligible. LCIS+ margins are allowed w/o additional resection.
- Mastectomy pts: Margins histol-free of residual (gross or microscopic) tumor.
- <70 days between last surgery for breast cancer (including re-excision of margins) & randomiz. If adjuv chemo was administered, must be <56 days between last chemo tx & randomiz.
- Recovered from surgery w/incision completely healed & no infection.
- If adjuv chemo used, any toxicity that may interfere w/RT should be resolved.
- No clinical or radiologic evidence of mets.
- No synchronous or prior contralateral invasive breast cancer or DCIS. Synchronous &/or prior contralateral LCIS is allowed.
- No prior (except index cancer) of ipsilateral invasive breast cancer or ipsilateral DCIS treated w/RT. Synchronous or prior ipsilateral LCIS is allowed.
- No prior non-breast malignancies (except in situ cancer treated by local excision & non-melanoma skin cancer) w/i 5 yrs pre-randomiz.
- No RT for currently diagnosed breast cancer pre-randomiz.
- No continued use of sex hormonal therapy. Must be discontinued pre-randomiz.
- No prior breast or thoracic RT for any condition.
- No active collagen vascular disease (i.e., dermatomyositis w/CPK level above normal), active skin rash, systemic lupus erythematosis, or scleroderma.
- No pregnant or nursing women at study entry. Pregnancy testing (if applicable) w/i 2 wks pre-randomiz.
- No other non-malignant systemic disease precluding study tx or required follow-up.
- No psychiatric/addictive disorders/other condition precluding study participation (investigator's opinion).
- PRE-STUDY REQUIREMENTS:
- Determination of local path dept's policy on submission of tumor samples
- Determination of hormone receptor status (b/f neoadjuv therapy was given)
- HER2 analysis (b/f neoadjuv therapy was given)
- H&P, ht, wt (physician or other healthcare professional)*
- Perf status*
- Menopausal status (at time of breast cancer dx)*
- CBC/diff/platelets (For all pts. Pts who receive adjuv chemo, testing must be >3 wks from last chemo dose.)*
- Pregnancy test (if applicable)**
- Bilat breast imaging***
- CT chest/abdomen/pelvis & bone scan or PET/CT (no evidence of mets on imaging between time of breast cancer dx & randomiz)
- BAHO (QOL/PROs) questionnaire**
- Tumor blocks (from prim breast tumor & definitive surgery) requested from local path dept.#
- Signed informed consent.
* Within 4 wks pre-randomiz
** Within 2 wks pre-randomiz
*** Within 12 mos pre-randomiz. MRI (not US) is permitted as a substitute for mammogram b/f entry. Unilateral imaging allowed for mastectomy pts w/ or w/o reconstruction.
# Before study entry, blocks must be requested & path dept must agree to release required tumor samples. Submit tumor materials w/i 90 days following randomiz.